Since the 1950's, transseptal procedures of the heart have been traditionally performed using Brockenbrough needles in which a puncture is made through an intact atrial septum from the right atrium to the left atrium. Several risks, however, have been associated with the use of Brockenbrough needles. One risk is the perforation of the lateral atrial wall after crossing the atrial septum. Another risk is the potential perforation of the aortic root.
Attempts have been made to reduce these and other risks. For example, U.S. Pat. No. 5,312,341 relates to the problem of inadvertent withdrawal of a catheter tip from the left atrium, through the atrial septum, and back into the right atrium. A retaining means for retaining the distal tip of a sheath which has been placed through a septum, such as the interatrial septum, across the septum, in the left atrium during left heart procedures was therefore proposed.
U.S. Pat. No. 6,650,923 relates to a method for accessing the left atrium by locating the fossa ovalis of the intra-atrial septum. An access catheter with a detector for identifying and providing access through the fossa ovalis was proposed.
U.S. Patent Publication No. 2006/0064062 relates to transseptal puncture needles and transseptal puncture needle assemblies. More specifically, it relates to curved transseptal puncture needles and needle assemblies that facilitate insertion through curved transseptal introducers. Each curved transseptal puncture needle includes a needle tip with a tangential back bevel configuration, a reverse tangential back bevel configuration, or a conical reverse bevel configuration.
U.S. Patent Publication No. 2005/0101984 relates to septal puncture in patients in which a communication is present between the two atria of the heart, for example, a patient with a patent foramen ovale (PFO). A device and method are proposed to safely puncture both an intact atrial septum and an atrial septum having a PFO. The proposed device includes a blunt outer needle, and a second inner needle disposed longitudinally through the lumen of the outer needle, wherein the inner needle is flexible, e.g., has a flexible portion and/or a bend or other non-traumatic conformation at its tip.
U.S. Patent Publication Nos. 2005/0159738 and 2005/0065507 relate to devices for septal perforation utilizing radio frequency energy. Each device includes a functional tip with at least one active electrode capable of creating a controlled perforation in body tissue. The device is introduced into the right atrium and the functional tip is positioned against the atrial septum. Energy is applied to the tip to create the perforation.
U.S. Pat. No. 6,890,353 relates to a method and apparatus for reducing mitral regurgitation by applying a force to the wall of the coronary sinus so as to force the posterior leaflet anteriorly and thereby reduce mitral regurgitation. A guidewire uses a sharp tip for allowing the distal end of a guidewire to penetrate tissue.
U.S. Patent Publication No. 2006/0241648 relates to methods and apparatus for modifying tissue. The proposed method includes advancing a beveled distal tip of a guide member to facilitate advancement of the guide member through tissue. A modification device is advanced along the guide member.
Nevertheless, there remains a need for improved devices and methods for perforating the intra-atrial septum of the heart with devices that improve the safety of the procedure.